Job Summary We are seeking a dedicated and detail-oriented Quality Manager to oversee our quality assurance processes and ensure compliance with industry standards. The ideal candidate will have a strong background in QA/QC methodologies, project management, and familiarity with FDA regulations. This role is crucial for maintaining the integrity of our products and ensuring that they meet both internal and external quality standards. Responsibilities Develop, implement, and maintain quality assurance protocols to ensure compliance with ISO 13485 and

ISO 9001

standards. Conduct regular quality audits and inspections to identify areas for improvement and ensure adherence to established procedures. Analyze data from quality inspections to identify trends, issues, and opportunities for enhancement in production processes. Collaborate with cross-functional teams to facilitate effective project management related to quality initiatives. Provide training and support to staff on quality assurance practices and FDA regulations. Oversee the fabrication process to ensure that all products meet specified quality criteria before release. Prepare detailed reports on quality metrics for management review and decision-making. Requirements Bachelor's degree in a relevant field or equivalent experience in Quality Assurance/Quality Control. Proven experience in QA/QC roles, with a strong understanding of FDA regulations and ISO standards (ISO 13485, ISO 9001). Strong analytical skills with the ability to interpret complex data sets related to quality inspections. Excellent project management skills, demonstrating the ability to lead initiatives effectively. Familiarity with conducting quality audits and implementing corrective actions as necessary. Strong communication skills, both verbal and written, with an emphasis on collaboration across departments. Detail-oriented mindset with a commitment to maintaining high-quality standards in all aspects of work. We invite qualified candidates who are passionate about quality assurance to apply for this pivotal role within our organization.

Job Type:

Full-time Pay:

$80,000.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Experience:

Quality Control:

4 years (Preferred) Ability to

Commute:

Lakewood, NJ 08701 (Preferred) Ability to

Relocate:

Lakewood, NJ 08701: Relocate before starting work (Preferred)

Work Location:

In person